An individual applicant may not submit more than one NIBIB
P30 Center application. However, there is no limit on the number of
applications an institution may submit provided that each application is
scientifically distinct. See Section
III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.286

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages
grant applications for Biomedical Technology Service Centers (P30 Centers)
that support infrastructure and resources that are needed by a diverse group
of funded NIH researchers, but are not widely available. Consistent with this
function, NIBIB P30 Centers should engage in dissemination activities and may
engage in training activities. Infrastructure and resources in an
NIBIB P30 Center could range from shared biomedical instrumentation to open
bioinformatics systems.

Key Dates

Posted Date

March 5, 2014

Open Date (Earliest Submission Date)

April 25, 2014

Letter of Intent Due Date(s)

Six weeks before the application due date.

Application Due Date(s)

May
25, 2014, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.

AIDS Application Due Date(s)

September
7, 2014, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.

Scientific Merit Review

October - November 2014

Advisory Council Review

January 2015

Earliest Start Date

April 2015

Expiration Date

September 8, 2014

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH’s new Application Submission System & Interface for
Submission Tracking (ASSIST) is available for the electronic preparation and
submission of multi-project applications through Grants.gov to NIH.
Applications to this FOA must be submitted electronically; paper applications
will not be accepted. ASSIST replaces the Grants.gov downloadable forms
currently used with most NIH opportunities and provides many features to enable
electronic multi-project application submission and improve data quality,
including: pre-population of organization and PD/PI data, pre-submission
validation of many agency business rules and the generation of data summaries
in the application image used for review.

Required Application Instructions

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH Guide for Grants and Contracts)
and where instructions in the Application Guide are directly related to the Grants.gov
downloadable forms currently used with most NIH opportunities. Conformance
to all requirements (both in the Application Guide and the FOA) is
required and strictly enforced. Applicants must read and follow all application
instructions in the Application Guide as well as any program-specific
instructions noted in Section IV. When
the program-specific instructions deviate from those in the Application Guide,
follow the program-specific instructions. Applications that do not
comply with these instructions may be delayed or not accepted for review.

The National Institute of Biomedical Imaging and
Bioengineering (NIBIB) supports Biomedical Technology Service Centers (NIBIB
P30 Centers) to ensure that independently funded investigators working in a
targeted area have access to biomedical technologies and expertise currently not
available. These Centers are expected to have a regional or national scope, serving
a significant number of investigators from multiple institutions outside the
applicant institution. Further, projects that receive service from the NIBIB
P30 Center should be highly regarded in their respective fields of research.

Specifically, a NIBIB P30 Center must have a sufficient
number of matured technologies or tools that can be deployed directly or, if
needed, requiring very limited development, to serve their user communities.
These technologies or tools must be unique and cutting edge, thus providing
important capabilities to their user communities that cannot be obtained in
other ways, including through commercial products or other institutions, both
domestic and international. Resources available in a typical NIBIB P30 Center
could include, but are not limited to, specialized shared instrumentation,
customized algorithms, novel tissue/organ engineering platforms, or open
bioinformatics systems.

The following exclusions apply: (1) NIBIB P30 Centers will
not support independent scientific research or unfunded pilot studies, except
for very limited development of novel technologies that support the NIBIB P30
Center service mission (see "Technology Service Cores" section).
(2) NIBIB will not support P30 Centers focusing on a specific disease, or involve
clinical trials or patient services. (3) NIBIB will not support P30 Centers
that overlap with pre-existing facilities at the host institution.

NIBIB P30 Centers shall consist of one Administrative Core, one
or more Technology Service Cores, associated Research Base Projects, and a
Dissemination Core. If appropriate, NIBIB P30 Centers may also
engage in training activities; in this case, a Technology Training Component should
be included.

The Administrative Core coordinates the different components
and activities of the NIBIB P30 Center including dissemination (and training,
if relevant).

Technology Service Cores provide a needed service to
investigators outside of the NIBIB P30 Center, supporting work that could not be
conducted, or could be conducted more efficiently and effectively, with the
resources of the P30 Center.

Each Technology Service Core shall have an associated
Research Base component consisting of projects that will utilize the Technology
Service Core. Investigators using the Technology Service Cores (i.e., the
"Research Base") are expected to have highly regarded existing
biomedical research programs funded by NIH Institutes or Centers, other Federal
Agencies, or other nationally or internationally recognized funding sources.

Consistent with their function to help the community gain
access to these resources, NIBIB P30 Centers must engage in dissemination
activities.

Finally, a NIBIB P30 Center must have an External Advisory
Committee (EAC) that advises the Program Director/Principal Investigator on
current operating procedures and future directions for the NIBIB P30 Center.

Because extensive planning is required in preparing NIBIB
P30 applications, prospective new applicants are strongly encouraged to discuss
their plans with the relevant NIBIB Program Directors (refer to www.nibib.nih.gov/Research/ProgramAreas)
well before the application is prepared.

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or
both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal
Resubmission

The OER
Glossary and the SF424 (R&R) Application Guide provide details on
these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations
and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are not limited but it is strongly
recommended that applicants not request a budget of more than $600,000 in
direct costs per year. In addition to the direct costs, a total cost for
equipment up to $500,000 can be requested for the duration of the five-year
project period.

Award Project Period

Support may be requested for up to five years.

NIH grants policies as described
in the NIH Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Applicant organizations must complete and maintain the
following registrations as described in the SF 424 (R&R) Application Guide
to be eligible to apply for or receive an award. All registrations must be
completed prior to the application being submitted. Registration can take 6
weeks or more, so applicants should begin the registration process as soon as
possible. The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.

Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
can begin both SAM and eRA Commons registrations. The same DUNS number must be
used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least
annually. The renewal process may require as much time as the
initial registration. SAM registration includes the assignment of a Commercial
and Government Entity (CAGE) Code for domestic organizations which have not
already been assigned a CAGE Code.

eRA Commons - Applicants
must have an active DUNS number and SAM registration in order to complete the
eRA Commons registration. Organizations can register with the eRA Commons as
they are working through their SAM or Grants.gov registration. eRA Commons requires
organizations to identify at least one Signing Official (SO) and at least one
Program Director/Principal Investigator (PD/PI) account in order to submit an
application.

Grants.gov – Applicants
must have an active DUNS number and SAM registration in order to complete the
Grants.gov registration.

Program
Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should
work with their organizational officials to either create a new account or to
affiliate an existing account with the applicant organization’s eRA Commons
account. If the PD/PI is also the organizational Signing Official, they must
have two distinct eRA Commons accounts, one for each role. Obtaining an eRA
Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always encouraged
to apply for NIH support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the
same as one already reviewed within the past thirty-seven months (as described
in the NIH
Grants Policy Statement), except for submission:

To an RFA of an application that was submitted previously as an
investigator-initiated application but not paid;

Of an investigator-initiated application that was originally
submitted to an RFA but not paid; or

Of an application with a changed grant activity code.

Section IV. Application
and Submission Information

1. Requesting an
Application Package

Applicants can access the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and
submit applications through Grants.gov to NIH. Applications prepared and
submitted using applicant systems capable of submitting electronic
multi-project applications to Grants.gov will also be accepted.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise and where instructions in the
Application Guide are directly related to the Grants.gov downloadable forms
currently used with most NIH opportunities. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

Core(s) (Use this component for each Technology Service
Core. Note: cores will appear in the application in the order in which they
were entered in ASSIST)

12

Dissemination Core

6

Technology Training

6

Additional page limits described in the SF424 Application
Guide and the Table of
Page Limits must be followed. For this FOA, there are page limitations for
the Research Base Section to be included in the Research & Related Other
Project Information form of the corresponding Technology Service Core:

Introduction for the Research Base Section (resubmissions
only): may not exceed 1 page

Summary of Research Base Projects: may not exceed 1 page

Description of Research Base Project: may not exceed 1 page
per Project for up to 10 Projects total excluding references.

Instructions for the Submission of Multi-Component
Applications

The following section supplements the instructions found in
the SF424 (R&R) Application Guide, and should be used for preparing a
multi-component application.

The application should consist of the following components:

Overall: required

Administrative Core: required

Technology Service Core(s): a minimum of one Technology Service
Core, required

Dissemination Core: required

Technology Training: optional

*
Note: Different from PAR-13-249, which requested the Research
Base Section to be included in the Appendix, the Research Base Section must be
included as Other Attachments under Research
& Related Other Project Information of the corresponding
Technology Service Core Component. Applications without Research Base(s)
relevant to proposed Technology Service Core(s) will be considered incomplete
and will not undergo peer review.

Overall Component

When preparing your application in ASSIST, use Component
Type ‘Overall’.

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Follow the instructions in the SF 424 (R&R)
Application Guide.

Human Embryonic Stem Cell lines from other
components should be repeated in cell line table in Overall component.

Research & Related Other Project
Information (Overall)

Follow standard instructions.

Project
Summary/Abstract: The application should include a succinct
project summary of the proposed work. State the proposed Center's broad,
long-term objective, specific aims, and the significance to the field of
Biomedical Imaging and/or Bioengineering. Define the relevance of each proposed
Technology Service Cores to the overall theme and goals of the program.

A
summary of Project/Performance Sites in the Overall section of the assembled
application image in eRA Commons compiled from data collected in the other
components will be generated upon submission.

Research & Related Senior/Key
Person Profile (Overall)

Include only the Project Director/Principal
Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the
entire application.

A
summary of Senior/Key Persons followed by their Biographical Sketches in the
Overall section of the assembled application image in eRA Commons will be
generated upon submission.

Budget (Overall)

The only budget information included in the Overall
component is the Estimated Project Funding section of the SF424 (R&R)
Cover.

A
budget summary in the Overall section of the assembled application image in eRA
Commons compiled from detailed budget data collected in the other components
will be generated upon submission.

PHS 398 Research Plan
(Overall)

Introduction
to Application: For Resubmission applications, an Introduction
to Application is required in the Overall component.

Specific
Aims: State concisely the goals of the proposed P30 Center.

Research
Strategy: Describe the overall objectives of the P30 Center,
and discuss what makes this particular P30 Center unique.

Give a brief overview of the Technology Service
Cores, and evaluate the regional and national need for the Technology Service
Cores.

Describe the qualifications of the PD(s)/PI(s).
He/she should be a highly experienced and respected scientist with demonstrated
administrative capabilities and a proven track record for obtaining NIH and/or
other relevant funding, as well as a track record of providing technical
service to the scientific community.

For New Applications, describe the factors and events
contributing to the decision to create the P30 Center.

For Renewal Applications, highlight major
accomplishments from the previous funding period, and point out major changes
from the original P30 Center design.

Letters
of Support: Attach all appropriate letters of support,
including any letters necessary to demonstrate the support of consortium
participants and collaborators such as senior/key personnel and Other
Significant Contributors included in the grant application. Letters are not
required for personnel (such as research assistants) not contributing in a
substantive, measurable way to the scientific development or execution of the
project. For consultants, letters should include rate/charge for consulting
services.

Multiple
PD/PI Leadership Plan: For applications designating multiple
PDs/PIs, a leadership plan must be attached. A rationale for choosing a
multiple PD/PI approach should be described. The governance and organizational
structure of the leadership team and the research project should be described,
and should include communication plans, process for making decisions on
scientific direction, and procedures for resolving conflicts. The roles and administrative,
technical, and scientific responsibilities for the project or program should be
delineated for the PDs/PIs and other contributors. If budget allocation is
planned, the distribution of resources to specific components of the project or
the individual PDs/PIs should be delineated in the Leadership Plan. In the
event of an award, the requested allocations may be reflected in a footnote on
the Notice of Award (NoA).

List all performance sites that apply to the Administration
component, which should be the same as the primary performance site(s).

Note: The Project Performance Site form allows up
to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key
Person Profile (Administration)

ASSIST will default to “Project Lead”. If you would
like to use a different category, then replace “Project Lead” below with a
different Category (e.g., Core Lead).

The PD/PI (or one of the PD(s)/PI(s)) of the P30
Center must be the Director of the Administrative Core.

In the Project Director/Principal Investigator
section of the form, use Project Role of ‘Other’ with Category of ‘Project
Lead’ and provide a valid eRA Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list
Senior/Key persons that are working in the component.

Include a single Biographical Sketch for each
Senior/Key person listed in the application regardless of the number of
components in which they participate. When a Senior/Key person is listed in
multiple components, the Biographical Sketch can be included in any one
component.

If more than 100 Senior/Key persons are included in a
component, the Additional Senior Key Person attachments should be used.

Budget (Administration)

Budget forms appropriate for the Administrative Core
will be included in the application package.

Personnel: The budget should include a detailed justification for key personnel. The
PD/PI or each of the PD(s)/PI(s) is expected to devote at least 3 calendar
months of his/her efforts to the P30 Center, with a minimum of 1.2 calendar
months being devoted to the Administrative Core. Salaries for support
positions in the P30 Center are permitted. No overlap of time and effort
between the P30 Center and other funded projects is permitted.

Supplies: Consumable supplies related to the operation of the P30 Center such as office
materials are permitted.

Equipment: Major equipment requests should be justified. Price quotes should
be included for equipment costing more than $25,000. General purpose laboratory
equipment and supply requests should be included only when necessary to support
visiting Research Base investigators.

Service
Contracts: Service Contracts for major equipment items are
allowed.

Travel: Domestic and foreign travel for P30 Center personnel is permitted, if the
travel is directly related to the activities of the P30 Center.

Consortium/Contractual
agreements: Funds may be requested for domestic
subcontracts. In general, funds may not be requested for foreign
subcontracts. Foreign subcontracts may be allowed if a written waiver is
provided by the NIBIB Associate Director.

Note: Funds may not be requested for alteration and
renovation, rental space, staff retreats, direct support for individual
research projects, or direct support for pilot studies.

Note:
The R&R Budget form included in many of the component types allows for up
to 100 Senior/Key Persons in section A and 100 Equipment Items in section C
prior to using attachments for additional entries. All other SF424 (R&R)
instructions apply.

PHS 398 Research Plan (Administration)

Introduction
to Application: For Resubmission applications, an Introduction
to Application is required for each component

Specific
Aims: State concisely the goals of the proposed Administrative
Core.

Research
Strategy: Describe the roles and contributions of other staff
who will be involved in the Administrative Core. Do not repeat information that
is included in the biosketches.

Describe the P30 Center organizational
structure. Discuss the relationship of the P30 Center to the
administrative structure of the grantee institution.

Describe the P30 Center operating procedures.
Discuss procedures to review requests for use of the equipment and facilities,
and to schedule use.

If a charge-back system that results in Center income
is planned, a description of how costs are to be shared by the users should be
included. Additionally, special administrative requirements that apply to
Center income must be observed.

The External Advisory Committee (EAC) is appointed by
the Director of the Administrative Core. External Advisory Committee
members and the chair should be from outside the host institution, and should
be rotated periodically.

Describe the role of the External Advisory
Committee. The External Advisory Committee chair should be knowledgeable
about the P30 Center technology and the science it serves, but should not be a
member of the P30 Center staff or a major user of the P30 Center. Other
committee members should be balanced among scientists knowledgeable about the
P30 Center technologies, experts in the application of P30 Center technologies
to biomedical research problems, and users of the technology.

For
new P30 grant applications, the External Advisory Committee should not be
constituted prior to or during the review of the application, and potential
candidates should not be approached or discussed.

For existing P30 Centers, list the current members of
the External Advisory Committee, and briefly describe their qualifications.

The External Advisory Committee must meet at least
annually and prepare a written report, addressed to the Director of the
Administrative Core, of its recommendations. This report must be supplied
as part of the P30 Center Annual Progress Report.

Describe the role of any local executive committees
that are proposed as adjuncts to the External Advisory Committee.

Letters
of Support: Do not include any letter of support here.

Resource
Sharing Plan: Not Applicable

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for
the Appendix as described in the SF424 (R&R) Application Guide.

External
Advisory Committee Report: For Renewal applications, include a copy
of the most recent EAC Report in the Appendix.

Planned Enrollment Report (Administration)

When conducting clinical research, follow all instructions
for completing Planned Enrollment Reports as described in the SF424 (R&R)
Application Guide.

PHS 398 Cumulative Inclusion
Enrollment Report (Administration)

When conducting clinical research, follow all
instructions for completing Cumulative Inclusion Enrollment
Report as described in the SF424 (R&R) Application Guide.

Technology Service Core(s)

When preparing your application in ASSIST, use Component
Type ‘Core’ for each Technology Service Core.

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions, as noted. NIBIB
P30 Centers must have a minimum number of one Technology Service Core.
However, if there is more than one Technology Service Core, each Technology
Service Core should be considered as a separate Component and described
separately.

SF424 (R&R) Cover (Technology
Service Core)

Complete only the following fields:

Project
leader Information

Type of
Applicant (optional)

Title of the
proposed Technology Service Core

Proposed Project
Start/Ending Dates of the proposed P30 Center

PHS 398 Cover Page Supplement (Technology
Service Core)

Follow the instructions in the SF424 (R&R)
Application Guide.

Research & Related Other Project
Information (Technology Service Core)

There must be a Research Base for each Technology
Service Core. This attachment must include a description of the Research Base.
In addition, provide a Table of all projects including the 10 representative
projects described in the Research Base. Each entry in the Table should
include:

Project
title

Name of
the PD/PI of the research base project

Institution
where the research base project take place

Details
of peer reviewed funding(s), including starting and ending dates.

Start and
end dates for the project(s)

Number of
publications that have resulted from the project (for Renewal applications
only)

Utilization
of human subjects or animals in the project (Yes/No)

References and overall Tables are not included in the
page limitations.

For Renewal applications, projects from the previous
funding period that are not being continued should be listed in a separate
Table.

In the body of the text for this section, begin the
section with a heading indicating "Research Base" followed by the
name of the Technology Service Core. Note:
the max number of characters for filenames is 50. Save the entire
section in a single file named, "Research Base-name of the Technology Service Core"
and upload this file under Other Attachments.

Project /Performance Site Location(s)
(Technology Service Core)

List all performance sites that apply to the specific
component.

Note:
The Project Performance Site form allows up to 300 sites, prior to using
additional attachment for additional entries.

Technology Service Core leaders should be
acknowledged experts in the technology provided by their respective Technology
Service Core (s). The PD(s)/PI(s) of the P30 Center may be the leader(s) of one
(or more) of the Technology Service Cores

In the Project Director/Principal Investigator
section of the form, use Project Role of ‘Other’ with Category of ‘Project
Lead’ and provide a valid eRA Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list
Senior/Key persons that are working in the component.

Include a single Biographical Sketch for each
Senior/Key person listed in the application regardless of the number of
components in which they participate. When a Senior/Key person is listed in
multiple components, the Biographical Sketch can be included in any one
component.

If more than 100 Senior/Key persons are included in a
component, the Additional Senior Key Person attachments should be used.

Budget (Technology Service Core)

Budget forms appropriate for the Technology Service
Core will be included in the application package.

Personnel:
The P30 Center can cover salaries for individual Technology Service Core leaders
to the extent that they provide an essential P30 Center function. Salaries
for technical or support positions in the P30 Center can also be requested.
No overlap of time or effort between the P30 Center and other funded
projects is permitted. The resources in the Technology Service Cores should be
equitably distributed: the maximum effort that a single Technology Service Core
can spend on projects directed by a single investigator is 25%.

The Technology Service Cores may support technicians
and engineers that have the appropriate scientific or engineering skills.
Examples of appropriate skills could be operation and maintenance of the
specialized shared instrumentation, implementation/support of customized algorithms,
assembly of existing components (without extensive modifications) for research platforms
and implementation/support of open bioinformatics systems. Where
appropriate, an established expert in the Technical Service Core activities
could also be included as a consultant.

Equipment: Without overlapping what is requested under other components, major equipment
requests should be justified. Price quotes should be included for equipment
costing more than $25,000. General purpose laboratory equipment and supply requests
should be included only when necessary to support visiting Research Base
investigators.

Note: Funds may not be requested for alteration and
renovation, rental space, staff retreats, direct support for individual
research projects, or direct support for pilot studies.

Note:
The R&R Budget form included in many of the component types allows for up
to 100 Senior/Key Persons in section A and 100 Equipment Items in section C
prior to using attachments for additional entries. All other SF424 (R&R)
instructions apply.

PHS 398 Research Plan (Technology
Service Core)

Introduction
to Application: For Resubmission applications, an Introduction
to Application is required for each component

Specific
Aims: State concisely the goals of the proposed Technology
Service Core.

Research
Strategy: Discuss the role and contributions of the leader(s)
of each Technology Service Core. Do not repeat information that is included in
the biosketches.

Describe the hardware, software and other specialized
facilities available to the Technology Service Core. Technology Service
Cores are expected to implement and maintain appropriate commercial equipment
and off-the-shelf software, and may also utilize specially designed equipment
and software. Finally, very limited developmental research is appropriate
if it directly enhances the utility of the Technology Service Cores.
Whenever possible, open-source software should be utilized. If an element
of the support provided by the P30 Center involves software or algorithm
development, it should be disseminated in open-source platforms and details
regarding the plan for software maintenance and documentation should be
provided.

A Technology Service Core should serve at least ten
independently-funded projects (Research Base). Briefly discuss how the technologies
or tools provided by this Technology Service Core are unique and cutting edge
and how they deliver important capabilities to their Research Base that cannot
be obtained in other ways.

Projects using a particular Technology Service Core
form a "Research Base" for that Technology Service Core. Each
Research Base must be described in detail in the Other Attachments section of
the relevant Technology Service Core.

For New Applications, each Technology Service Core
should include information on preliminary studies.

For Renewal Applications, each Technology Service
Core should include a Progress Report.

Letters
of Support: Attach all appropriate letters of support,
including any letters necessary to demonstrate the support of consortium
participants and collaborators such as senior/key personnel and Other
Significant Contributors included in the grant application. Letters are not
required for personnel (such as research assistants) not contributing in a
substantive, measurable way to the scientific development or execution of the
project. For consultants, letters should include rate/charge for consulting
services. Letters of support from PDs/PIs of Research Base projects are NOT
required and should not be included.

Note:
The Project Performance Site form allows up to 300 sites, prior to using
additional attachment for additional entries.

Research & Related Senior/Key
Person Profile (Dissemination Core)

In the Project Director/Principal Investigator
section of the form, use Project Role of ‘Other’ with Category of ‘Project
Lead’ and provide a valid eRA Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list
Senior/Key persons that are working in the component.

Include a single Biographical Sketch for each
Senior/Key person listed in the application regardless of the number of
components in which they participate. When a Senior/Key person is listed in
multiple components, the Biographical Sketch can be included in any one
component.

If more than 100 Senior/Key persons are included in a
component, the Additional Senior Key Person attachments should be used.

Budget (Dissemination Core)

Budget forms appropriate for the Dissemination Core
will be included in the application package.

Personnel: The budget should include a
detailed justification for key personnel under this component. The person
months for each member of the P30 Center staff related to this component should
be included here. It is possible to have overlapped personnel under different
components, as long as their total efforts do not exceed 100% under the entire
P30 Center.

Web Site: Cost is allowed for the development and
maintenance of a web site.

Note: Funds to support courses given for academic or
other types of credit are not allowed. Funds may not be requested for
alteration and renovation, rental space, staff retreats, direct support for
individual research projects, or direct support for pilot studies.

Note:
The R&R Budget form included in many of the component types allows for up
to 100 Senior/Key Persons in section A and 100 Equipment Items in section C
prior to using attachments for additional entries. All other SF424 (R&R)
instructions apply.

PHS 398 Research Plan (Dissemination
Core)

Introduction
to Application: For Resubmission applications, an Introduction
to Application is required for each component

Specific
Aims: State concisely the goals of the proposed Dissemination
Core.

Research
Strategy: A fundamental motivation for the NIBIB P30 Center
program is to apply cutting-edge technology to important biomedical research
problems. The realization of this goal depends on an effective
Dissemination Program. Researchers are encouraged to share data obtained using
the facilities of the P30 Center. Scientific and technical staffs are
encouraged to share information on the technologies available at the P30
Center.

Describe the details of the Dissemination
Program. Dissemination activities should inform the scientific community
about the technical capabilities of the P30 Center, and promote and enable a
broader use of the technologies.

A variety of approaches can be proposed to promote
dissemination. These approaches include, but are not limited to: publishing
book chapters, patents, newsletters, or annual reports; conducting workshops;
distributing software products; transferring technologies to other
laboratories; and licensing technologies to industry.

Website Requirement: All P30s are expected to have a
robust web presence that clearly acknowledges support from the NIBIB. The
website should provide information about:

The P30’s
service focus and capabilities

Contact
information

How to
establish Research Base projects

Links to
online tutorials

The
availability of software, reagents, and other resources (as applicable)

For Renewal applications,
include a link to a list of all publications that have resulted from the
center's efforts since its inception.

Letters
of Support: Attach all appropriate letters of support,
including any letters necessary to demonstrate the support of consortium
participants and collaborators such as senior/key personnel and Other
Significant Contributors included in the grant application. Letters are not
required for personnel (such as research assistants) not contributing in a
substantive, measurable way to the scientific development or execution of the
project. For consultants, letters should include rate/charge for consulting
services.

Note:
The Project Performance Site form allows up to 300 sites, prior to using
additional attachment for additional entries.

Research & Related Senior/Key
Person Profile (Technology Training)

In the Project Director/Principal Investigator
section of the form, use Project Role of ‘Other’ with Category of ‘Project
Lead’ and provide a valid eRA Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list
Senior/Key persons that are working in the component.

Include a single Biographical Sketch for each
Senior/Key person listed in the application regardless of the number of
components in which they participate. When a Senior/Key person is listed in
multiple components, the Biographical Sketch can be included in any one
component.

If more than 100 Senior/Key persons are included in a
component, the Additional Senior Key Person attachments should be used.

Budget (Technology Training)

Budget forms appropriate for the Technology Training
Core will be included in the application package.

Personnel: The budget should include a detailed justification for key personnel under this
component. The person months for each member of the P30 Center staff related to
this component should be included here. It is possible to have overlapped
personnel under different components, as long as their total efforts do not
exceed 100% under the entire P30 Center.

Note: Individuals benefiting from the training
experience may not be paid a stipend nor may the training experience be a requirement
for receipt of an academic degree. Trainee-related costs such as stipends,
fringe benefit, travel, and room and board are not allowed.

Note:
The R&R Budget form included in many of the component types allows for up
to 100 Senior/Key Persons in section A and 100 Equipment Items in section C
prior to using attachments for additional entries. All other SF424 (R&R)
instructions apply.

PHS 398 Research Plan (Technology
Training)

Introduction
to Application: For Resubmission applications, an Introduction
to Application is required for each component

Specific
Aims: State concisely the goals of the proposed Technology Training.

Research
Strategy: The Technology Training Program (if present and
appropriate for the P30 Center) should create a cadre of biomedical researchers
that are trained in the P30 Center technologies, and can effectively apply them
to their own research. Participants may range from graduate students, to
faculty members and practicing physicians, to researchers from industry as is
appropriate for the P30 Center's technology.

The choice of approaches should be informed by the
special constraints and opportunities presented by the individual P30 Center. A
defining feature of technology training activities is the potential for onsite
and/or direct interaction between P30 Center personnel and the users or
students. Note that activities such as web-based self-service tutorials would
fall under Dissemination, since there is no direct interaction between P30
Center personnel and the users or students.

Examples of successful approaches include hands-on
laboratory experience such as residencies in the P30 Center laboratories,
seminars and lectures, and short courses or symposia offered independently or
in conjunction with society meetings attended by the user community. Another
example would be workshops that bring together researchers from academic
institutions, hospitals, and industry for discussions on the P30 Center's
technology. Because of the increasing importance of translational and clinical
research, plans for technology training for researchers involved in those
efforts are encouraged.

Letters
of Support: Attach all appropriate letters of support,
including any letters necessary to demonstrate the support of consortium
participants and collaborators such as senior/key personnel and Other
Significant Contributors included in the grant application. Letters are not
required for personnel (such as research assistants) not contributing in a
substantive, measurable way to the scientific development or execution of the
project. For consultants, letters should include rate/charge for consulting
services.

Resource
Sharing Plan: Not Applicable

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for
the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Training)

When conducting clinical research, follow all
instructions for completing Planned Enrollment Reports as described in the
SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion
Enrollment Report (Training)

When conducting clinical research, follow all
instructions for completing Planned Enrollment Reports as described in the
SF424 (R&R) Application Guide.

3. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications
before the due date to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants
across all Federal agencies) using ASSIST or other electronic submission
systems. Applicants must then complete the submission process by tracking the
status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants
are responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.

Important
reminders:All PD(s)/PI(s) and component Project Leads must include their
eRA Commons ID in the Credential fieldof the Senior/Key Person Profile
Component of the SF424(R&R) Application Package. Failure to register
in the Commons and to include a valid PD/PI Commons ID in the credential field
will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management (SAM). Additional information
may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review, NIH. Applications that are
incomplete will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in
any year (excluding consortium F&A) must contact NIBIB program staff at least 6 weeks before
submitting the application and follow the Policy on the Acceptance for Review
of Unsolicited Applications that Request $500,000 or More in Direct Costs as
described in the SF424 (R&R) Application Guide.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact - Overall

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the P30 Center to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
P30 Center proposed).

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a P30 Center that by its nature is
not innovative may be essential to advance a field.

Significance

Does the P30 Center address an important problem or a
critical barrier to progress in the field? If the aims of the P30 Center are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

Additional review criteria for NIBIB P30 Centers:
Will the P30 Center have a significant influence on the biomedical research
output of the funded investigators in the Research Base in ways that would not
be feasible for individual research projects?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers
well suited to the P30 Center? If Early Stage Investigators or New
Investigators, or in the early stages of independent careers, do they have
appropriate experience and training? If established, have they demonstrated an
ongoing record of accomplishments that have advanced their field(s)? If the
project is collaborative or multi-PD/PI, do the investigators have
complementary and integrated expertise; are their leadership approach,
governance and organizational structure appropriate for the project?

Additional review criteria for NIBIB P30
Centers: Are the PD(s)/PI(s) well qualified to effectively administer the
P30 Center? Are the PD(s)/PI(s), the Technology Service Core leaders and other
key personnel appropriately trained for their respective roles? Are they
able to devote adequate effort to the P30 Center activities? Do they have
a history of performing services for their colleagues or the scientific
community at large, outside of the needs of their own research?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?

For NIBIB P30 Centers "Innovation" is defined
as a coherent plan to ensure that independently funded investigators have
access to biomedical technologies and expertise that are not widely available and
will substantially increase the capabilities of other funded research.

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the P30 Center?
Are potential problems, alternative strategies, and benchmarks for success presented?
If the project is in the early stages of development, will the strategy
establish feasibility and will particularly risky aspects be managed?

If the P30 Center involves human subjects and/or NIH-defined clinical research,
are the plans to address 1) the protection of human subjects from research risks,
and 2) inclusion (or exclusion) of individuals on the basis of sex/gender,
race, and ethnicity, as well as the inclusion or exclusion of children,
justified in terms of the scientific goals and research strategy proposed?

Additional review criteria for NIBIB P30
Centers: Do the Technology Service Cores provide advanced technologies and
services that are not easily available to investigators in the Research
Base? Are they appropriate for the anticipated research needs of PD/PIs
in the Research Base? Do the PD/PIs using the Technology Service Cores
(i.e., the Research Base) have highly-regarded existing biomedical research
programs funded by NIH Institutes or Centers, other Federal Agencies, or other
nationally or internationally-recognized funding sources? Does the Research
Base have a regional and/or national geographic distribution?

Are plans for the administration of the P30 Center
appropriate?

For New applications, are the plans for the External Advisory Committee appropriate?

For Renewal applications, is the role of the External Advisory Committee appropriate? Do
the members of the External Advisory Committee have sufficient breadth and
ability to take an effective role in the review and guidance of P30 operations?
Is there evidence that the External Advisory Committee is active?

Are plans to provide dissemination appropriate? Are
sufficient activities planned that inform the scientific community about the
technical capabilities of the P30 Center, and promote and enable a broader use
of the technologies? Does the Dissemination Plan assure that appropriate users
will have fair access to the facilities and service?

Is there a robust web presence, or is one planned?

For P30s that are developing software, is the
software portable when appropriate, well-documented, user-friendly, and readily
available to the user community?

When applicable, does the Technology Training Plan
ensure that a cadre of trained biomedical Researchers can apply the P30 Center
technologies effectively in their own research?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements?

Additional Review Criteria - Overall

As applicable for the P30 Center proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give
separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Guidelines
for the Review of Human Subjects.

Inclusion of Women, Minorities, and
Children

When the proposed project involves human subjects
and/or NIH-defined clinical research, the committee will evaluate the proposed
plans for the inclusion (or exclusion) of individuals on the basis of
sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of
children to determine if it is justified in terms of the scientific goals and
research strategy proposed. For additional information on review of the
Inclusion section, please refer to the Guidelines
for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary
care; 4) procedures for limiting discomfort, distress, pain and injury to that
which is unavoidable in the conduct of scientifically sound research including
the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable
restraining devices; and 5) methods of euthanasia and reason for selection if
not consistent with the AVMA Guidelines on Euthanasia. For additional
information on review of the Vertebrate Animals section, please refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the
application as now presented, taking into consideration the responses to
comments from the previous scientific review group and changes made to the
project.

Renewals

For Renewals, the committee will consider the
progress made in the last funding period.

Revisions

Not Applicable

Additional Review Considerations - Overall

As applicable for the P30 Center proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.

Applications from Foreign
Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by the National
Institute of Biomedical Imaging and Bioengineering, in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact
score.

Will receive a written critique.

Applications will be assigned to the appropriate NIH
Institute or Center. Applications will compete for available funds with all
other recommended applications submitted in response to this FOA. Following
initial peer review, recommended applications will receive a second level of
review by the National Advisory Council of the NIBIB. The following will be
considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the
proposed project to program priorities.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

When multiple years are involved, awardees will be required
to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR)
annually and financial statements as required in the NIH
Grants Policy Statement.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH Grants
Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting
requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and
405 of the Public Health Service Act as amended (42 USC 241 and 284) and under
Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.